Pristina Serena 3D
K-Number: K182951 · 2019-01-18
ApplicantGE Healthcare
Decision Date2019-01-18
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Pristina Serena 3D is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2019-01-18 under approval number K182951. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pristina Serena 3D?
Pristina Serena 3D is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by GE Healthcare. The 510(k) number is K182951.
When was Pristina Serena 3D approved by the FDA?
Pristina Serena 3D received FDA 510(k) clearance on 2019-01-18, under approval number K182951.
What company makes Pristina Serena 3D?
Pristina Serena 3D is manufactured by GE Healthcare.
What is the FDA product code for Pristina Serena 3D?
The FDA product code for Pristina Serena 3D is MUE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.